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Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique

Predictive Value of Granulosa Cell DNA Damage in the Success of Assisted Reproductive Technique

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05558046
Enrollment
60
Registered
2022-09-28
Start date
2022-10-01
Completion date
2023-06-20
Last updated
2022-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DNA Damage, Granulosa Cells

Keywords

Ovarian Reserve, Flow Cytometry, Sperm Injections, Intracytoplasmic

Brief summary

Deoxyribonucleic acid (DNA) damage of granulosa cells obtained during oocyte retrieval will be evaluated by flow cytometry with detection of Histone H2A.X and Phosphorylated Gamma H2A.X protein levels in patients with low ovarian reserve and unexplained infertile patients as a control group undergoing intracytoplasmic sperm injection (ICSI) treatment. Fertilization, embryo quality, transfer rate, implantation, clinical pregnancy will be recorded as well as demographic data. DNA damage of granulosa cells will be compared between two groups. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Detailed description

Granulosa cells surrounding the oocytes will be mechanically obtained during the oocyte pick-up procedure in women undergoing intracytoplasmic sperm injection (ICSI) treatment due to unexplained infertility and low ovarian reserve. Deoxyribonucleic acid (DNA) damage in these cells will be evaluated by flow cytometry. Fertilization rates, embryo quality by grading, and transfer rates will also be assessed. Implantation and clinical pregnancy rates will be recorded as well as demographic data such as age, body-mass index, smoking, alcohol use, employment, coexisting chronic disease, infertility duration, etiology of infertility, treatment protocol. Implantation will be evaluated by determination of serum human chorionic gonadotropin (hCG) at day 15 following an embryo transfer. Clinical pregnancy will be diagnosed upon presence of gestational sac on ultrasound examination. DNA damage of granulosa cells will be compared between low ovarian reserve group and control group. The effect of DNA damage of granulosa cells on fertilization, quality of oocyte and embryo, implantation, and clinical pregnancy will be also evaluated.

Interventions

None listed

Sponsors

Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

* For patients who are undergoing in Vitro Fertilization (IVF) treatment with Low ovarian reserve, Antimullerian Hormone level must be lower than 1 ng/mL * For patients who are undergoing in Vitro Fertilization (IVF) treatment with Unexplained infetility, Antimullerian Hormone level must be greater than 1,5 ng/mL

Exclusion criteria

* Chronic systemic disease (rheumatoid arthritis, hypertension, diabetes..) * Endocrinopathy (Thyroid, prolactin... abnormalities) * Chemotherapy or radiotherapy history * Endometriosis * Policystic ovary syndrome * Male infetility

Design outcomes

Primary

MeasureTime frameDescription
Determining the correlation of ovarian reserve and age factor with DNA Damage markers in granulosa cells.1 dayDemographic data will be noted for each patient at the day of oocyte retrieval, and DNA damage markers will be shown by flowcytometry at the same day.

Secondary

MeasureTime frameDescription
Fertilization defined as the presence of two pronuclei under light microscope one day after intracytoplasmic sperm injection procedure1 day after ICSI procedurePresence of two pronuclei under light microscope
Implantation defined as positive serum human chorionic gonadotropin levels 12 days after embryo transfer12 days after embryo transferPositive human chorionic gonadotropin levels
Clinical pregnancy will be defined as the presence of gestational sac in transvaginal ultrasonographic examination 5 weeks after embryo transfer5 weeksPresence of a gestational sac in transvaginal ultrasonographic examination

Contacts

Primary ContactErman Ciftci, MD
ermanciftci1@gmail.com+905074422414

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026